EverCross™ AB35W04150135 (UDI 00643169973534)Recalls & reported problems
Ev3, Inc · PTA AB35W04150135 EVERCROSS 035 V08 · Class 2
All models of EverCross (114)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169973534), received between Mar 13, 2024 and Mar 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2024Delivered as Unsterile Product; Delivered as Unsterile Product
AN EVERCROSS PTA BALLOON WAS INTENDED TO BE USED FOR TREATMENT OF AN UNKNOWN LESION IN THE POPLITEAL ARTERY AND TIBIAL POPLITEAL TRUNK. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY IT WAS FOUND TO BE OPEN. IT IS NOT 100% CONFIRMED BUT IT IS BELIEVED THE PACKAGING WAS ALREADY OPENED AND SEAL WAS NOT INTACT IN THE MIDDLE. THE DEVICE WAS NOT USED IN THE PATIENT. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INVOLVEMENT WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18893136 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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